Home NDC 62135-468 Primidone
Product NDC 62135-468
11-digit product format 621350468
Labeler code 62135
Product ID 62135-468_45ae0446-2685-d868-e063-6394a90ab581
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Primidone
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA084903
Marketing category ANDA
Marketing start 2001-05-24
Substance PRIMIDONE
Active strength 50 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A084903-001 PRIMIDONE PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 A084903-002 PRIMIDONE PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A084903-001 PRIMIDONE 250MG TABLET / ORAL AB Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A084903-002 PRIMIDONE 50MG TABLET / ORAL AB 2001-05-24 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Primidone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRIMIDONE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 13AFD7670Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198150 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-468-90 Primidone 90 in 1 BOTTLE TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-468 PRIMIDONE TABLET [CHARTWELL RX, LLC] 1 Current NDC, 1 package rows 20230415_4a8e309f-d89e-4b1a-abb2-856a66ebbff9.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Primidone PRIMIDONE Chartwell RX, LLC 4a8e309f-d89e-4b1a-abb2-856a66ebbff9 2025-12-11 Warnings, Adverse reactions Exact identifier application applno (ANDA): 084903 application number: ANDA084903 ndc (product): 62135-468 Primidone PRIMIDONE Golden State Medical Supply, Inc e4e493bd-94d7-7e5a-e053-2995a90a2706 2024-12-23 Warnings, Adverse reactions Exact identifier application applno (ANDA): 084903 application number: ANDA084903 Primidone PRIMIDONE American Health Packaging a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11 2024-10-03 Warnings, Adverse reactions Exact identifier application applno (ANDA): 084903 application number: ANDA084903 Primidone PRIMIDONE Aphena Pharma Solutions - Tennessee, LLC ad8b50e2-e797-4326-a57e-d254da85b6b9 2024-01-09 Warnings, Adverse reactions Exact identifier application applno (ANDA): 084903 application number: ANDA084903 Primidone PRIMIDONE Lannett Company, Inc. a1a817f7-c190-4825-94eb-442f477187e3 2020-06-11 Warnings, Adverse reactions Exact identifier application applno (ANDA): 084903 application number: ANDA084903
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62135-468-90 62135046890 90 TABLET in 1 BOTTLE (62135-468-90) 90 tablet 2023-04-11 No No Current